DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
The amended claim set filed on 16 October 2025 is acknowledged. Claims 12-26 are currently pending. Of those, claims 12, 15-16, 18, 22, 24, and 26 are amended. There are no new claims and no claims are withdrawn. Claims 1-11 are cancelled. Claims 12-26 will be examined on the merits herein.
Response to Amendment
The Applicants’ arguments filed 16 October 2026 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 16 July 2025 will be referred to “NFOA”.
Objection(s) and Rejection(s) Withdrawn
The objection to claims 12, 15-16, and 24 are withdrawn in view of the amendments to the claims.
The rejections of claims 12, 19, 22, and 26 under 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of the amendments to the claims.
Rejection(s) Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 112
Claim 18 remains rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 18, which is amended to depend upon claim 12, recites, “the ratio of carrier protein to 22F saccharide is between 1:2 and 2.5:1 (w/w).” (i.e., there can be more 22F (1:2) or more carrier protein (2.5:1)) However, claim 12 recites, “the ratio of carrier protein to the 22F saccharide is between 4:1 and 1:1 (w/w)” (i.e., there are equal amounts of the carrier and 22F (1:1) or there is more carrier protein (4:1)). The lower end of the range of carrier protein to 22F saccharide recited in claim 18 (i.e., 1:2, more 22F than protein) is lower than the lower end of the range recited in claim 12. Thus, claim 18 fails to include all limitations of claim 12 because the scope of the range in claim 18 is broader than those recited in claim 12.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Response to Arguments
Applicant argues (Remarks, pg. 6) that “Claim 26 [sic] has been amended to depend from claim 12.”
This argument has been fully considered but is not persuasive. This argument is not persuasive because the rejection above has been amended to reflect the claim amendments.
Claim Rejections - 35 USC § 103
Claims 12-26 remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Laferriere (WO 2003/051392 A2; cited in IDS; herein “Laferriere”) as evidenced by Arnon et al. (US4474757A) in view of Ryall (WO 99/18121 A1) for the reasons of record and the reasons herein.
The following rejection has been amended to reflect the amendments to the claims.
Regarding claims 12 and 17-22, Laferriere teaches a multivalent Streptococcus pneumoniae vaccine comprising at least 13 different polysaccharides from different S. pneumoniae serotypes (pg. 5, lines 4-11) conjugated to two or more carrier proteins (pg. 2, lines 5-11), and that the preferred serotypes may be 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, and 23F (pg. 5, lines 12-14). Laferriere also teaches that the carrier proteins may be diphtheria toxoid (DT), tetanus toxoid (TT), CRM197, fragment C of TT, PhtD, and protein D (pg. 4, lines 25-33). Laferriere teaches that the polysaccharides may be directly linked to the carrier proteins using 1-cyano-dimethylaminopyridinium tetrafluoroborate (CDAP) conjugation chemistry (pg. 6, lines 1-7). Laferriere also teaches that the size of the S. pneumoniae saccharides may be 100-500 kDa (pg. 5, lines 20-21) and the ratio of carrier protein to S. pneumoniae saccharide may be 0.7 to 1.5 or 0.9 to 1.1 (w/w) for one or more serotypes (pg. 5, lines 24-27). Regarding the limitation, “wherein the immunogenic composition is formulated as a paediatric vaccine”, Laferriere teaches a method to elicit a protective immune response to infants (i.e., pediatric population) against S. pneumoniae by administering the polysaccharide conjugate vaccine (e.g., a multivalent vaccine comprising at least 13 capsular saccharide conjugates including 22F saccharide conjugate) (pg. 2, lines 15-17).
With respect to the limitation, “wherein the immunogenic composition is formulated as a paediatric vaccine”, MPEP 2111.04 states: "Claim scope is not limited by… claim language that does not limit a claim to a particular structure.” This “wherein” clause is interpreted as an intended use for the claimed composition because the claim and instant specification do not make clear that formulation as a pediatric vaccine results in a structural difference in the immunogenic composition. A recitation of the intended use of the claimed invention (“a paediatric vaccine”) must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. When the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978). See also MPEP 2111.02 for a discussion of intended uses in the preamble and MPEP 2112 for a discussion of inherency.
Regarding the ranges of claims 12 and 17-22, the average S. pneumoniae polysaccharide size of 100-500 kDa taught by Laferriere (pg. 5, lines 20-21) anticipates the range 50-800 kDa recited in claim 12 and the ranges 50-1600, 80-1400, and 100-1000 kDa recited in claim 22, and the range of carrier protein to polysaccharide ratio greater than 0.5 to 1.7 (w/w) anticipates the range 1:2 to 2.5:1 (w/w) recited in claim 18.
Regarding claim 13, Laferriere teaches that 6B, 19F, and/or 23F saccharides may be conjugated to a first carrier protein and the remaining saccharides are conjugated to one or two secondary carrier proteins that are different from the first carrier protein, i.e., two different carrier proteins are conjugated to at least two different S. pneumoniae saccharide serotypes (pg. 2, lines 7-10).
Regarding claims 14 and 16, Laferriere teaches that the S. pneumoniae polysaccharides may be linked to the carrier proteins by any known method and points to US Pat. No. 4,474,757 (pg. 5, lines 32-33). ‘757 provides evidence that known methods of producing vaccines comprising antigenic peptide conjugates linked to carrier proteins include by carbodiimide chemistry using 1-ethyl-3-(3’-dimethylaminopropyl)carbodiimide hydrochloride (specifically, see col. 3, lines 18-20).
Regarding claim 18, the ratio of carrier protein to polysaccharide may be greater than 0.5 to 1.7 (i.e., greater than 1:2 to 1.7:1 (w/w)) (pg. 5, lines 23-24).
Regarding claim 23, Laferriere teaches that the vaccine may further comprise S. pneumoniae surface proteins (i.e., conjugated or unconjugated proteins) (pg. 2, line 13).
Regarding claim 24, Laferriere teaches that the S. pneumoniae surface proteins may be from the Poly Histidine Triad (PhtX) family, Choline Binding Protein (CbpX) family, the CbpX truncate family, LytX family, LytX truncates, CbpX truncate-LytX truncate chimeric proteins, pneumolysin (Ply), PspA, PsaA, Sp128, Sp101, Sp130, Sp125, and Sp133 (pg. 2, lines 13-14 and pg. 7, line 17 – pg., 11, line 6).
Regarding claims 25-26, Laferriere teaches that the vaccine may be adjuvanted (i.e., further comprising an adjuvant) and that a suitable adjuvant may be aluminum phosphate (pg. 11, lines 32-33). Laferriere also teaches that the ratio of aluminum salt to polysaccharide in the vaccine may be less than 10:1 (w/w), preferably less than 8:1 and more than 2:1 (pg. 12, lines 3-4) and that the vaccine may be stored in 0.5mL solution/dose (i.e., one dose comprises 0.5mL) (pg. 14, lines 9-10). Laferriere teaches four different 11-valent vaccines comprising a total polysaccharide content of about 42 µg, 32 µg, 60 µg, or 37 µg, and an aluminum content of about 210 µg, 160 µg, 320 µg, or 190 µg, respectively, which is roughly equal to an aluminum to polysaccharide ratio of 5:1 for each vaccine composition (pg. 24, Table 2).
However, Laferriere does not teach a ratio of carrier protein to S. pneumoniae saccharide ratio between 4:1 and 1:1 (w/w), as in claim 12, at least one S. pneumoniae capsular saccharide that is conjugated to a carrier protein via a linker that is ADH, as in claim 15, a ratio of carrier protein to 22F saccharide between 1:1 and 3.5:1, 1.2:1 and 3:1, or 1.5:1 and 2.5:1 (w/w), a ratio of carrier protein to saccharide greater than 1:1, as in claim 19, a 22F saccharide with an average size that is greater than 100 kDa, as in claim 20, or between 110-700, 110-300, 120-200, 130-180, or 150-170 kDa, as in claim 21, or an at-least-13-valent vaccine with an adjuvant comprising 100-750, 200-500, or 300-400 µg of Al per 0.5 mL dose, as in claim 26.
Regarding claims 12 and 14-16, Ryall teaches methods of producing polysaccharide conjugates using small molecules, such as adipic acid dihydrazide (ADH) as a linker because the inherent reactivity of the molecule allows it to selectively bind to proteins (pg. 3, last para. – pg. 4, para. 2). In their examples, Ryall teaches a method of producing S. pneumoniae polysaccharide conjugates by (for each serotype) attaching ADH to a polysaccharide using EDAC and mixing the adipic dihydrazide derivatized polysaccharide with Diphtheria toxoid to obtain S. pneumoniae polysaccharides of different serotypes independently linked via ADH to DT as a carrier protein (Examples 2-3 and 5-6, pg. 35-39 and 41). Ryall teaches that this process has been successfully performed with capsular polysaccharides from S. pneumoniae serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F (pg. 11, para. 3).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art at the time of the claimed invention, to use the S. pneumoniae polysaccharides from at least 13 different serotypes and two or more of the carrier proteins taught by Laferriere in the method of producing S. pneumoniae polysaccharide conjugates taught by Ryall, thereby arriving at the claimed invention. The person of ordinary skill in the art would have been motivated to make the modification because Ryall teaches that using ADH as a linker affords selective attachment to proteins and the inherent reactivity of ADH allows polysaccharides from different serotypes (i.e., polysaccharides which may vary in structure and reactivity) to consistently be linked to carrier proteins. Therefore, the combination is also desirable (see MPEP 2144(II)). The person of ordinary skill in the art would have had a reasonable expectation of success because Laferriere teaches that the polysaccharides and carrier proteins may be linked by any known method and Ryall teaches the methodological details to achieve that result. Additionally, Ryall has used this method on a many of the polysaccharide serotypes taught by Laferriere, so one would predict that the method would work with any of the remaining serotypes.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e., S. pneumoniae capsular saccharides, carrier proteins, linkers, and ADH) were known in the art. In addition, combining these elements yields a composition wherein each element merely performs the same function as it does separately; thus, the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
The average size of the 22F saccharide in claim 20 (at least 100 kDa) and claim 21 (110-700, 110-300, 120-200, 130-180, or 150-170 kDa) are obvious variants of the range cited in Laferriere (100-500 kDa; pg. 5, lines 20-21), because the range taught by Laferriere significantly overlaps or encompasses the claimed ranges. Similarly, the ranges of carrier protein to polysaccharide ratios (w/w) in claim 12 (between 1:1 and 4:1), claim 17 (1:1 – 3:1, 1.2:1 – 3, or 1.5:1 – 2.5:1), and claim 19 (greater than 1:1) are obvious variants of those taught by Laferriere (>0.5:1 – 1.7:1, 0.7:1 – 1.5:1, 0.8:1 – 1.5:1, and 0.9 – 1:1), because each of the ranges taught by Laferriere overlap with one or more of the claimed ranges. It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
The claimed ranges of aluminum in the immunogenic composition of claim 26 could be obtained by one of ordinary skill in the art by routine experimentation, because Laferriere teaches four 11-valent polysaccharide conjugate compositions containing from about 160-320 µg aluminum per dose depending on the saccharide content of the vaccine (pg. 24, Table 2). In order to produce the claimed composition comprising polysaccharide conjugates from 13 different S. pneumoniae serotypes, one need only determine the polysaccharide content of the 13-valent vaccine and adjust the amount of aluminum in the composition, both of which would have been considered routine in the art. The courts have found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). It is noted that the courts have held that optimization through routine experimentation, and in particular, when related to differences in concentration, do not support patentability, unless there is evidence indicating such concentration is critical (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). See MPEP 2144.05(II). Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Response to Arguments
Applicant argues (Remarks, pg. 7-9) that Laferriere does not teach a composition formulated as a pediatric vaccine comprising the claimed 22F saccharide conjugate and that Laferriere does not teach or discuss the design of a 22F saccharide conjugate in a pediatric vaccine, or data regarding the immunogenicity of a 22F saccharide conjugate in an infant vaccine. Applicant also points to an example 13-valent composition taught by Laferriere that does not comprise 22F conjugate as evidence that Laferriere does not teach or suggest a pediatric vaccine comprising serotype 22F.
This argument has been fully considered but is not persuasive, As set forth in the amended rejection under 35 U.S.C. 103 above, the newly-added limitation, “wherein the immunogenic composition is formulated as a paediatric vaccine,” is interpreted as an intended use of the claimed immunogenic composition because Applicant has not established that formulation as a pediatric vaccine results in a structural difference between the claimed composition and the vaccine taught by Laferriere. Nevertheless, Laferriere does teach that the vaccine may be administered to infants in order to elicit a protective immune response against S. pneumoniae infection (pg. 2, lines 15-17), i.e., the composition taught by Laferriere may be formulated as a pediatric vaccine. Laferriere teaches that the vaccine composition may comprise from 11 to 23 different serotypes (i.e., including a vaccine comprising at least 13 serotypes), and teaches that the serotypes included in the vaccine may include serotype 22F saccharide. Thus, one of ordinary skill in the art would “at once envisage” a multivalent conjugate vaccine comprising the recited saccharides, including 22F. MPEP 2131.02(III) states: A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)). Regarding the design of the 22F conjugate (i.e., the size and protein-to-saccharide ratio parameters), Laferriere teaches that the “polysaccharides of the invention” (i.e., any and all of the saccharides taught by Laferriere, including 22F) are sized to a range of 100-500 kD, which anticipates the claimed range of 50-800 kD, and that the ratio of protein to polysaccharide is 0.5-1.7 (i.e., 1:2-1.7:1) for at least seven serotypes, which is an obvious variant of the claimed range of 1-4 (i.e., 4:1 to 1:1). The courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art,” a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985)) (see MPEP 2144.05.01).
Regarding the argument that Laferriere does not provide data on a vaccine comprising the 22F saccharide conjugate, MPEP 2143.02(I) states, “Conclusive proof of efficacy is not required to show a reasonable expectation of success.” Because Laferriere teaches a multivalent vaccine composition which may comprise conjugates of the 13 recited S. pneumoniae serotype saccharides (i.e., including 22F), one of ordinary skill in the art would have a reasonable expectation of successfully producing a vaccine comprising 22F saccharide conjugate using the conjugation method taught by Ryall, as is set forth in the 103 rejection of the NFOA and that above, absent evidence to the contrary.
Regarding the argument that the cited examples in Laferriere do not contain 22F saccharide, MPEP 2123(II) states, “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Laferriere teaches that the multivalent vaccine, which may be a 13-valent vaccine, may comprise 22F saccharide conjugates; thus, the examples do not teach away from that embodiment.
Applicant argues (Remarks, pg. 8) that Laferriere teaches that “there remains ‘technical difficulties in combining multiple polysaccharide conjugates into a single, efficacious, vaccine formulation.’”
This argument has been fully considered but is not persuasive. Applicant does not point to evidence of “technical difficulties” in preparing the claimed immunogenic composition or expound upon what those technical difficulties might be, either in the arguments or in the instant specification. The examples of the instant specification (starting on pg. 43) demonstrate applicant tested a total of four different combinations of serotypes (see Table 2 and pg. 55, lines 1-9). Of those, the 11-valent composition was formulated in two different ways (i.e., using two different adjuvants) and the 13-valent composition was formulated using five different 22F conjugates (i.e., using PhtD or a PhtD_E fusion and either GMBS or formaldehyde for detoxification, or using directly conjugated 22F) (see Tables 15-17 and pg. 68, ln. 33 – pg. 69, ln. 4) or was formulated using a single 22F conjugate and nine different adjuvants (see pg. 74-75). All of the formulations tested were effective as vaccines (see para. Tables 8-12 and 14-17) . All of the adjuvants used are known in the art and one of ordinary skill in the art and no “technical difficulties” were reported in the process of formulating the compositions or in the results. Regarding the different 22F conjugates, the instant specification does not report any “technical difficulties” in the methods of producing the conjugates or in the results. Therefore, Applicant has not shown that the allegedly expected “technical difficulties” are severe enough to prevent there being a reasonable expectation of successfully combining the teachings of Laferriere and Ryall, either by independent evidence or by the teachings of the specification.
Applicant argues (Remarks, pg. 8) that Butler et al. and Flamaing et al. demonstrate that infection of 22F serotype S. pneumoniae in children was rare at the time of filing, and that “infant vaccines would not benefit from the addition of the 22F saccharide.”
This argument has been fully considered but is not persuasive. Applicant has not described, either in the Remarks or the instant specification, how formulation as a pediatric vaccine results in a structural change to the immunogenic composition that makes the claimed invention patentably distinct from the vaccine taught by Laferriere. Thus, teachings from the art regarding the prevalence of 22F serotype infections in infants are not sufficient to constitute a teaching away from including the 22F saccharide in an immunogenic composition. Laferriere teaches that 22F saccharide may be included in a multivalent conjugate vaccine; thus, one of ordinary skill in the art would be motivated to include a 22F saccharide conjugate in an immunogenic composition, as is taught by Laferriere, described in the 103 rejection of the NFOA and in the amended rejection above.
Applicant argues (Remarks, pg. 8-9) that examples 8 and 9 of the instant specification demonstrate an unexpectedly high level of immunogenicity of the 22F saccharide conjugate in young mice.
This argument has been fully considered but is not persuasive. Tables 15-17 show that the immune response to 22F conjugates is not unexpectedly high compared to other serotype conjugates and is comparable to the response generated against most other serotype conjugates present in the composition. MPEP 716.02(a)(I)states: “Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991)” The specification does not state that the immunogenicity results obtained were unexpected; this is only a conclusion presented in the arguments. Applicant is advised that MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, Applicant should not merely rely upon counsel’s arguments in place of evidence in the record.
Applicant argues (Remarks, pg. 9) that “using native or slightly sized polysaccharide conjugates was advantageous” and that the selected ranges (e.g., 50-800 kDa for 22F and a carrier-protein-to-22F-saccharide ratio of 1:1-4:1) provides high immunogenicity.
This argument has been fully considered but is not persuasive. MPEP 716.01(b) states (emphasis added): “Applicant or patent owner bears the burden of establishing a nexus between the objective evidence of nonobviousness and the claimed invention. See In re Huang, 100 F.3d 135, 140, 40 USPQ 1685, 1689 (Fed. Cir. 1996). Nexus is presumed when the applicant or patent owner shows that the asserted objective evidence of record is tied to a certain product and that product includes the claimed features, and is coextensive with them. See Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373, 2019 USPQ2d 483355 (Fed. Cir. 2019), cert. denied, 141 S.Ct. 373 (2020).” Table 2 of the instant specification teaches that only a small range of 22F saccharide size (159-167 kDa) and protein-to-22F-saccharide ratio range of 2.17-4.34 was tested; thus, the size and protein-to-saccharide ratio ranges are not commensurate in scope with the claimed invention, which claims a range of 50-800 kDa and protein-to-saccharide ratio of 4:1-1:1 for the 22F saccharide, and Applicant has not established a nexus between the evidence relied upon and the claimed invention.
Applicant argues (Remarks, pg. 9-10) that there is not a finite number of predicted solutions with anticipated success and points to Eisai Co. Ltd. v. Dr. Reddy’s Labs., Ltd., 533 F.3d 1353, 87 USPQ2d 1452 (Fed. Cir. 2008) and provides a list of subject matter that one would need to select to arrive at the claimed invention.
This argument has been fully considered but is not persuasive. Regarding Eisai Co. Ltd. v. Dr. Reddy’s Labs., Ltd. (herein “Eisai”), the court found that the composition was nonobvious because “no reason had been advanced to modify the prior art compound in a way that would destroy an advantageous property…. The trifluoro substituent of lansoprazole was known to be a beneficial feature because it conferred lipophilicity to the compound. The ability of a person of ordinary skill to carry out the modification to introduce the methoxypropoxy substituent, and the predictability of the result were not addressed.” (see MPEP 2143(I)(B), Example 9) The instant situation is distinct from the situation in Eisai because Applicant has not pointed to an advantageous property that would have been destroyed by the combination of Laferriere and Ryall set forth in the 103 of the NFOA. In fact, the previous rejection and that above sets forth that the combination would be beneficial (not destructive to a beneficial property) because Ryall teaches that using ADH as a linker affords selective attachment to proteins and the inherent reactivity of ADH allows polysaccharides from different serotypes (i.e., polysaccharides which may vary in structure and reactivity) to consistently be linked to carrier proteins, and that one would have a reasonable expectation of successfully combining the teachings of Laferriere and Ryall because the conjugates of Laferriere may be produced by any known method and Ryall teaches the methodological details to successfully produce S. pneumoniae saccharide conjugates (see para. 26-27 above).
Regarding the argument that one of ordinary skill in the art would have to make six different selections in order to arrive at the claimed invention, five of the six selections are described in Laferriere, i.e., multivalent vaccine comprising at least 13 saccharide conjugates, both combinations of saccharides and carrier proteins, the size of 22F, and use as a pediatric vaccine. The remaining selection, the protein-to-22F-saccharide ratio of 4:1 to 1:1, is an obvious variant of the ratio of 1:2 to 1.7:1 taught by Laferriere, as set forth in the previous 103 rejection and in that above. Furthermore, Applicant has not provided any evidence that the claimed range of protein-to-22F-saccharide yields unexpected results across the full scope claimed that would render the claimed range nonobvious over the range taught by Laferriere or that the combination of the teachings of Laferriere and Ryall would not have a reasonable expectation of success.
Applicant argues (Remarks, pg. 10-11) that it is improper to use applicant’s disclosure as a blueprint to reconstruct the claimed invention and to use hindsight reasoning to find prior art components.
This argument has been fully considered but is not persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As set forth in the rejection under 35 U.S.C. 103 in the NFOA and the amended rejection above, all elements were known in the art at the time of filing and one of ordinary skill in the art would have had a reasonable expectation of successfully combining the teachings of Laferriere and Ryall to arrive at the claimed invention based on that was known in the art at the time of filing.
New Objection(s)
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Specifically, the amino acid sequence on pg. 45, line 27 is not identified by a SEQ ID NO.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY M MORGAN whose telephone number is (703)756-5388. The examiner can normally be reached M-F 9-5 ET.
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/BAILEY M MORGAN/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645